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Observational Study
. 2020 Apr:138:91-97.
doi: 10.1016/j.urology.2019.11.041. Epub 2019 Dec 30.

Determining Clinically Based Factors Associated With Reclassification in the Pre-MRI Era using a Large Prospective Active Surveillance Cohort

Justin R Gregg  1 , John W Davis  2 , Chad Reichard  2 , Xuemei Wang  3 , Mary Achim  2 , Brian F Chapin  2 , Louis Pisters  2 , Curtis Pettaway  2 , John F Ward  2 , Seungtaek Choi  4 , Quynh-Nhu Nguyen  4 , Deborah Kuban  4 , Richard Babaian  2 , Patricia Troncoso  5 , Lydia T Madsen  6 , Christopher Logothetis  7 , Jeri Kim  8
Affiliations
Observational Study

Determining Clinically Based Factors Associated With Reclassification in the Pre-MRI Era using a Large Prospective Active Surveillance Cohort

Justin R Gregg et al. Urology. 2020 Apr.

Abstract

Objective: To report biopsy-related and oncologic outcomes in a large prospective active surveillance cohort that was initiated in the premagnetic resonance imaging era and to additionally identify clinical factors associated with disease reclassification in order to inform future studies designed to improve enrollment and follow-up on active surveillance.

Methods: Patients were prospectively enrolled at a single institution from 2006 to 2014 and followed until 2016. Men with Gleason 6 or 7 disease were eligible, and those with >6 months follow-up were included in the analysis. Patients were risk stratified based on clinical/pathologic criteria, including based on a combination of baseline and confirmatory biopsy tumor characteristics. Reclassification-free survival, based on tumor volume increase or Gleason score increase, was analyzed using multivariable Cox proportional hazards models.

Results: Of 825 enrolled patients, 682 met inclusion criteria. Median follow-up was 40 months (range 6.6-126.8). Disease was reclassified in 249 (36.5%), and 157 (23.0%) underwent treatment. A single positive core with a negative confirmatory biopsy was significantly associated with time to reclassification (median not met vs 43 months, log rank test P <.001). Composite tumor length, defined as the combined tumor length between baseline and confirmatory biopsies, was associated with shorter Gleason upgrade-free survival (hazard ratio 1.24, 95% confidence interval 1.11-1.40, P <.001) in multivariable analysis.

Conclusion: Baseline stratification using clinical factors including tumor length may refine risk stratification and offer the foundation on which new systems that incorporate modalities such as magnetic resonance imaging may be based.

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Figures

Fig. 1 –
Fig. 1 –. Study participant enrollment and outcomes.
Flowchart showing patients included in the active surveillance cohort, reclassification rates, reasons for reclassification, and numbers who were treated or left the study for other reasons. GS, Gleason score; AS, active surveillance.
Fig. 2 -
Fig. 2 -. Kaplan Meier survival analysis of grade group progression by composite tumor length tertiles.
Cox proportional hazard multivariate model including composite tumor length, age, PSA and total number of positive cores revealed worsened progression-free survival for composite tumor length of 1.25–3.5mm (HR 1.73, 95CI 1.01–2.96, P=0.05) and >3.5mm (HR 3.03, 95CI 1.60–5.75, P<0.01) compared to the reference length of 0.25–1.24mm.
See this image and copyright information in PMC

Comment in

  • EDITORIAL COMMENT.
    Toren P. Toren P. Urology. 2020 Apr;138:97. doi: 10.1016/j.urology.2019.11.057. Urology. 2020. PMID: 32252959 No abstract available.

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